BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014980·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 6

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507554·Gutta Percha Points is used to root canal filin...

    FORMATK MAGMA PLATFORM LASER

    FDA Adverse Event
    Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

    IND ONE STEP OCCULT BLOOD (FOB) TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

    FORMATK MAGMA PLATFORM

    FDA Adverse Event
    Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

    QUADRA ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

    PROTECTA XT DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    NICO Model 7300 Cardiopulmonary Management System

    FDA Recall
    Terminated ·Respironics Novametrix, LLC.·Product code CCK·August 11, 2006

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021